- Marketing authorization application for BCG Unresponsive
Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ
(CIS) submitted to European Medicines Agency (EMA) in December 2024
and anticipated acceptance of application in 2025
- Marketing authorization application for BCG Unresponsive NMIBC
CIS submitted to United Kingdom’s Medicines and Healthcare products
Regulatory Agency (MHRA) in November 2024 and anticipated
acceptance of application in 2025
- ImmunityBio responding to requests for information from both
Agencies and the potential for approval in European Union and
United Kingdom by 2026
ImmunityBio, Inc. (NASDAQ: IBRX) today announced the completion
of the submissions of its marketing authorization applications
(MAA) for ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus
Calmette-Guérin (BCG) for the treatment of adult patients with
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with
carcinoma in situ (CIS), with or without papillary tumors, to both
the European Union (EU) European Medicines Agency (EMA) and the
United Kingdom's (UK) Medicines and Healthcare products Regulatory
Agency (MHRA).
The EMA covers 27 countries in the EU, as well as Iceland,
Norway, and Liechtenstein. The assessment is expected to be
complete by the fourth quarter of 2025. Similarly, the UK
assessment of the MAA is anticipated to be completed by the fourth
quarter of 2025. ImmunityBio is in continued dialog for requests
for information from the two agencies, with the potential of
approval by 2026.
“The submission of our applications to EMA and MHRA represents a
significant milestone in our efforts to address this critical need
and improve patient outcomes globally,” said Dr. Patrick
Soon-Shiong, Founder, Executive Chairman and Global Chief
Scientific and Medical Officer of ImmunityBio.
ImmunityBio continues to make strides in its mission to provide
innovative therapies for patients with limited treatment options.
The U.S. launch of ANKTIVA for NMIBC CIS has gained momentum, with
the product now widely accessible through commercial and government
insurance programs. The company recently announced the unique,
permanent Healthcare Common Procedure Coding System (HCPCS) J-code
(J9028) assigned by the Centers for Medicare & Medicaid
Services (CMS) in the United States for ANKTIVA® (nogapendekin alfa
inbakicept-pmln) under J9028 (Injection, nogapendekin alfa
inbakicept-pmln, for intravesical use, 1 microgram). To date,
commercial and governmental insurance cover over 240 million lives
for ANKTIVA.
About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of key immune cells—NK and CD8+ killer T cells—that are
involved in killing cancer cells. By activating NK cells, ANKTIVA
overcomes the tumor escape phase of clones resistant to T cells and
restores memory T cell activity with resultant prolonged duration
of complete response.
ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion
complex, consisting of an IL-15 mutant (IL-15N72D) fused with an
IL-15 receptor alpha, which binds with high affinity to IL-15
receptors on NK, CD4+, and CD8+ T cells. This fusion complex of
ANKTIVA mimics the natural biological properties of the
membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic
cells and drives the activation and proliferation of NK cells with
the generation of memory killer T cells that have retained immune
memory against these tumor clones. The proliferation of the
trifecta of these immune killing cells and the activation of
trained immune memory results in immunogenic cell death, inducing a
state of equilibrium with durable complete responses. ANKTIVA has
improved pharmacokinetic properties, longer persistence in lymphoid
tissues, and enhanced anti-tumor activity compared to native,
non-complexed IL-15 in-vivo.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company
developing next-generation therapies and vaccines that bolster the
natural immune system to defeat cancers and infectious diseases.
The Company’s range of immunotherapy and cell therapy platforms,
alone and together, act to drive and sustain an immune response
with the goal of creating durable and safe protection against
disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the
first FDA-approved immunotherapy for non-muscle invasive bladder
cancer CIS that activates natural killer cells, T cells, and memory
T cells for a long-duration response. The Company is applying its
science and platforms to treating cancers, including the
development of potential cancer vaccines, as well as developing
immunotherapies and cell therapies that we believe sharply reduce
or eliminate the need for standard high-dose chemotherapy. These
platforms and their associated product candidates are designed to
be more effective, accessible, and easily administered than current
standards of care in oncology and infectious diseases. For more
information, visit ImmunityBio.com and connect with us on X
(Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, such as statements regarding EMA and MHRA regulatory
submissions and the potential acceptance and review thereof,
including timing associated with such review, commercial launch
activities and market access initiatives, medical insurance
coverage and reimbursement, market data, clinical trial data and
potential results to be drawn therefrom, the development of
therapeutics for cancer and infectious diseases, potential benefits
to patients, potential treatment outcomes for patients, the
described mechanism of action and results and contributions
therefrom, potential future uses and applications of ANKTIVA and
use in cancer vaccines and across multiple tumor types, and
ImmunityBio’s approved product and investigational agents as
compared to existing treatment options, among others. Statements in
this press release that are not statements of historical fact are
considered forward-looking statements, which are usually identified
by the use of words such as “anticipates,” “believes,” “continues,”
“goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,”
“may,” “plans,” “potential,” “predicts,” “indicate,” “projects,”
“is,” “seeks,” “should,” “will,” “strategy,” and variations of such
words or similar expressions.
Statements of past performance, efforts, or results of our
preclinical and clinical trials, about which inferences or
assumptions may be made, can also be forward-looking statements and
are not indicative of future performance or results.
Forward-looking statements are neither forecasts, promises nor
guarantees, and are based on the current beliefs of ImmunityBio’s
management as well as assumptions made by and information currently
available to ImmunityBio. Such information may be limited or
incomplete, and ImmunityBio’s statements should not be read to
indicate that it has conducted a thorough inquiry into, or review
of, all potentially available relevant information. Such statements
reflect the current views of ImmunityBio with respect to future
events and are subject to known and unknown risks, including
business, regulatory, economic and competitive risks,
uncertainties, contingencies and assumptions about ImmunityBio,
including, without limitation, (i) whether the EMA and/or MHRA will
accept the submissions referenced herein for filing on the
anticipated timeline or at all, (ii) whether the EMA and/or MHRA
will ultimately approve such submissions and the risks and
uncertainties associated with the regulatory review process and
timing thereof, (iii) risks and uncertainties regarding commercial
launch execution, success and timing, (iv) risks and uncertainties
regarding market access initiatives and timing, (v) whether
clinical trials will result in registrational pathways and the
risks and uncertainties regarding the regulatory submission, review
and approval process, (vi) whether clinical trial data will be
accepted by regulatory agencies, (vii) the ability of ImmunityBio
to continue its planned preclinical and clinical development of its
development programs through itself and/or its investigators, and
the timing and success of any such continued preclinical and
clinical development, patient enrollment and planned regulatory
submissions, (viii) potential delays in product availability and
regulatory approvals, (ix) ImmunityBio’s ability to retain and hire
key personnel, (x) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (xi) potential
product shortages or manufacturing disruptions that may impact the
availability and timing of product, (xii) ImmunityBio’s ability to
successfully commercialize its approved product and product
candidates, (xiii) ImmunityBio’s ability to scale its manufacturing
and commercial supply operations for its approved product and
future approved products, and (xiv) ImmunityBio’s ability to
obtain, maintain, protect, and enforce patent protection and other
proprietary rights for its product candidates and technologies.
More details about these and other risks that may impact
ImmunityBio’s business are described under the heading “Risk
Factors” in the Company’s Form 10-K filed with the U.S. Securities
and Exchange Commission (SEC) on March 19, 2024 and the Company’s
Form 10-Q filed with the SEC on November 12, 2024, and in
subsequent filings made by ImmunityBio with the SEC, which are
available on the SEC’s website at www.sec.gov. ImmunityBio cautions
you not to place undue reliance on any forward looking statements,
which speak only as of the date hereof. ImmunityBio does not
undertake any duty to update any forward-looking statement or other
information in this press release, except to the extent required by
law.
Indication and Important Safety Information
INDICATION AND USAGE: ANKTIVA is an interleukin-15
(IL-15) receptor agonist indicated with Bacillus Calmette-Guérin
(BCG) for the treatment of adult patients with BCG-unresponsive
nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ
(CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder
Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the
development of muscle invasive or metastatic bladder cancer, which
can be lethal. If patient with CIS do not have a complete response
to treatment after a second induction course of ANKTIVA with BCG,
reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do
not administer by subcutaneous or intravenous routes. Instill
intravesically only after dilution. Total time from vial puncture
to the completion of the intravesical instillation should not
exceed 2 hours.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal
harm. Advise females of reproductive potential of the potential
risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥15%) adverse
reactions, including laboratory test abnormalities, are increased
creatinine, dysuria, hematuria, urinary frequency, micturition
urgency, urinary tract infection, increased potassium,
musculoskeletal pain, chills and pyrexia.
For more information about ANKTIVA, please see the Full
Prescribing Information at www.anktiva.com.
You are encouraged to report negative side effects of
prescription drugs to FDA.
Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also
contact ImmunityBio at 1-877-ANKTIVA (1-877-265-8482)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250115024418/en/
Investors Hemanth Ramaprakash, PhD, MBA +1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton +1-415-290-8045
Sarah.singleton@immunitybio.com
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